1. CTD Module 4: Non-Clinical Studies SPC Relevant Scientific information
1.Pharmacology
1.Primary Pharmacodynamics
2.Secondary Pharmacodynamics
3.Safety Pharmacology
4.Pharmacodynamic Drug Interactions
2.Pharmacokinetics
1.Analytical Methods and Validation
2.Absorption
3.Distribution
4.Metabolism
5.Excretion
6.Pharmacokinetic Drug Interactions
7.Other Pharmacokinetic Studies
Toxicology:
Acute toxicity
Subchronic toxicity
Tissue specific toxicity
Tolerability
In vivo testing Animal model
Drug action:
Behaviour and reaction
Physiology
Histopathology

2. PHARMACODYNAMICS (M 4)

3. Pharmacodynamics (PD) Pre-clinical
“What the drug does to the body”
Drug Mode of Action, Potency, Efficacy
Molecular level and Animal Studies (Module 4):
What type of drug is it?
Describe its action at?
Selective or non-selective?
Binding reversible or irreversible?
The doses and the effects?
Human (Module 5):
Dose/dose relationships, onset of action and duration of action
Discontinuation of treatment
Beneficial effects on mortality and morbidity
Therapeutic Index/Therapeutic Window – safety aspect 3

4. Mode of action – outcome

5. Potency and Efficacy

6. Therapeutic Response – Window and Adverse Effects